Is the BNT162b2 SARS-CoV-2 vaccine safe in children younger than 5 years?
In this cohort study based on a survey of guardian-reported safety profiles of BNT162b2 in 7806 children, higher dosages of BNT162b2 were significantly associated with injection-site reactions. Compared with approved non–SARS-CoV-2 vaccines, BNT162b2 was associated with significantly more frequent injection-site, musculoskeletal, dermatologic, or otolaryngologic symptoms but fewer general symptoms and fever after vaccination.
In this study, the overall frequency of adverse events after vaccination with BNT162b2 was comparable with the frequency of adverse events after vaccination with approved non–SARS-CoV-2 vaccines in children younger than 5 years.
SARS-CoV-2 vaccines are authorized for use in most age groups. The safety of SARS-CoV-2 vaccines is unknown in children younger than 5 years.
To retrospectively evaluate the safety of the BNT162b2 vaccine used off-label in children younger than 5 years compared with the safety of non–SARS-CoV-2 vaccines in the same sample.
Design, Setting, and Participants
This investigator-initiated retrospective cohort study included parents or caregivers who registered children for SARS-CoV-2 vaccination in outpatient care facilities in Germany. The study was performed as an authenticated online survey. A total of 19 000 email addresses were contacted from vaccination registration databases between April 14 and May 9, 2022. Inclusion criteria were child age younger than 5 years at the first BNT162b2 vaccination and use of a correct authentication code to prove invitation.
Off-label BNT162b2 vaccination and on-label non–SARS-CoV-2 vaccinations.
Main Outcomes and Measures
Reported short-term safety data of 1 to 3 doses of 3 to 10 μg BNT162b2 in children from birth to younger than 60 months are presented. Coprimary outcomes were the frequencies of 11 categories of symptoms after vaccination with bivariate analyses and regression models adjusting for age, sex, weight, and height.
The study included 7806 children (median age, 3 years [IQR, 2-4 years]; 3824 [49.0%] female) who were followed up of for a mean (SD) of 91.4 (38.8) days since first BNT162b2 vaccination (survey response rate, 41.1%). A 10-μg dosage was more frequently associated with local injection-site symptoms compared with lower dosages. In the active-comparator analysis, the probability of any symptoms (odds ratio [OR], 1.62; 95% CI, 1.43-1.84), local symptoms (OR, 1.68; 95% CI, 1.38-2.05), musculoskeletal symptoms (OR, 2.55; 95% CI, 1.32-4.94), dermatologic symptoms (OR, 2.18; 95% CI, 10.7-4.45), or otolaryngologic symptoms (OR, 6.37; 95% CI, 1.50-27.09) were modestly elevated after BNT162b2 compared with non–SARS-CoV-2 vaccines, whereas the probabilities of general symptoms (OR, 0.77; 95% CI, 0.63-0.95) and fever (OR, 0.42; 95% CI, 0.32-0.55) were lower after BNT162b2. Symptoms requiring hospitalization (n = 10) were reported only at BNT162b2 dosages above 3 μg.
Conclusions and Relevance
In this cohort study, the symptoms reported after BNT162b2 administration were comparable overall to those for on-label non–SARS-CoV-2 vaccines in this cohort of children younger than 5 years. The present data may be used together with prospective licensure studies of BNT162b2 efficacy and safety and could help guide expert recommendations about BNT162b2 vaccinations in this age group.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: August 31, 2022.
Published: October 18, 2022. doi:10.1001/jamanetworkopen.2022.37140
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2022 Toepfner N et al. JAMA Network Open.
Corresponding Author: Cho-Ming Chao, MD, PhD, Department of Pediatrics, HELIOS University Medical Center, Witten/Herdecke University, Heusnerstr 40, 42283 Wuppertal, Germany (email@example.com).
Author Contributions: Drs Strumann and Chao had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Toepfner and von Meißner are co–first authors. Drs M.B. Moor and Chao are co–senior authors.
Concept and design: Toepfner, von Meißner, J. Moor, M.B. Moor, Chao.
Acquisition, analysis, or interpretation of data: Toepfner, von Meißner, Strumann, Drinka, Berner, M.B. Moor, Chao.
Drafting of the manuscript: Toepfner, von Meißner, Strumann, Drinka, Stuppe, Jorczyk, J. Moor, Püschel, Liss, Poblotzki, Berner, M.B. Moor, Chao.
Critical revision of the manuscript for important intellectual content: Toepfner, von Meißner, Strumann, J. Moor, Berner, M.B. Moor, Chao.
Statistical analysis: Strumann.
Administrative, technical, or material support: Toepfner, von Meißner, Drinka, Stuppe, Jorczyk, Püschel, Liss, Chao.
Supervision: Toepfner, Chao.
Design of the questionnaire: Toepfner, von Meißner, Drinka, Stuppe, Jorczyk, J. Moor, M.B. Moor, Chao.
Conflict of Interest Disclosures: Dr J. Moor reported receiving funding from the Swiss Society of General Internal Medicine Foundation and the Swiss Academy of Medical Sciences outside the submitted work. Drs Drinka, Toepfner, and Berner and Mr Jorczyk were supported by University Medical Center Dresden. Dr M. B. Moor was supported by University Hospital Bern and the National Competence Center of Research-Kidney. Dr Chao was supported by University Medical Center Rostock. No other disclosures were reported.
Additional Contributions: The authors are thankful to all participating vaccination centers and respondents. We acknowledge the nonprofit assistance for participant recruitment provided by the Bildung Aber Sicher and U12Schutz initiatives and by Anke Böhnke, MD (Frauenarztpraxis, Berlin, Germany), Armin Philipp, MD (Hautarztpraxis, Stuttgart, Germany), Georg Hillebrand, MD (Klinik für Kinder- und Jugendmedizin, Itzehoe, Germany), Lisa Degener, MD (Hausärztliche Gemeinschaftspraxis, Altenberge, Germany), and Lisa Schneider, MD (Gemeinschaftspraxis Dres Albrecht/Winkler, Laupheim, Germany). No one was compensated for their work.
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